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GCE NEW HEALTH

Low Risk

FEI: 3014471892 • Mississauga, Ontario • CANADA

FEI

FEI Number

3014471892

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA
🏢

Address

2-2299 Drew Rd, , Mississauga, Ontario, Canada

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
7/9/2018
Latest Refusal
7/9/2018
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3201×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
7/9/2018
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
16DIRECTIONS
320LACKS FIRM
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GCE NEW HEALTH's FDA import refusal history?

GCE NEW HEALTH (FEI: 3014471892) has 1 FDA import refusal record(s) in our database, spanning from 7/9/2018 to 7/9/2018.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. GCE NEW HEALTH's FEI number is 3014471892.

What types of violations has GCE NEW HEALTH received?

GCE NEW HEALTH has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about GCE NEW HEALTH come from?

All FDA import refusal data for GCE NEW HEALTH is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.